DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/16/2026 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Status of Claims
Applicant’s amendment filed 04/16/2026 is acknowledged. Claims 23 and 29 have been amended. Claims 1-22 and 24 have been cancelled. Claims 23 and 25-33 are pending in the instant application and the subject of this non-final office action.
All of the amendments and arguments have been reviewed and considered. Any rejections or objections not reiterated herein have been withdrawn in light of amendments to the claims or as discussed in this office action.
New Ground(s) of Rejections
Previous Rejection
Status of Prior Rejections/Objections:
The drawings objection is withdrawn in view of the amendment to the drawings.
The claim objections are withdrawn in part. The additional items directed solely to claim 29 do not appear to have been addressed; these objections are maintained.
The prior art rejection(s) under 35 USC 103 directed to the following are maintained and clarified:
Claim(s) 23 and 25-32 as being unpatentable over Fredriksson in view of Walker, as evidenced by MSK, NEB, and NEB – Ends
Claim 33 as being unpatentable over Fredriksson in view of Walker, as evidenced by MSK, NEB, and NEB – Ends, and further in view of Patel
The non-statutory double patenting rejections of over US 10,081,825 B2 in view of Fredriksson, Walker, and Patel, as evidenced by MSK, NEB, and NEB – Ends has been modified upon further consideration.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29:
In step (k), the claim recites “includes a 5’’ phosphate group”; there is an extra apostrophe after the 5.
In step (n), the claim recites “having a 5’ segment” at the second to third lines of the step. There appears to be an extra line break/tab in the formatting.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 23 and 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over Fredriksson (WO 2008/033442 A2; as cited in the IDS dated 02/11/2025) in view of Walker (Walker GT, et al. Strand displacement amplification--an isothermal, in vitro DNA amplification technique. Nucleic Acids Res. 1992 Apr 11;20(7):1691-6), as evidenced by MSK (DNA damage recognition and repair by DNA ligases. Memorial Sloan Kettering Institute. Accessed 2024 Nov 12. Available at: https://www.mskcc.org/research/ski/labs/stewart-shuman/dna-damage-recognition-and-repair-dna-ligases), NEB (Reverse Transcription (cDNA synthesis), New England Biolabs. Accessed: 2024 Nov. 13. Available at: https://www.neb.com/en-us/applications/cloning-and-synthetic-biology/dna-preparation/reverse-transcription-cdna-synthesis), and NEB – Ends (What ends will PCR products have? [Internet]. New England Biolabs; 2023 [cited 2025 Oct 11]. Available from: https://www.neb.com/en-us/faqs/2023/07/25/what-ends-will-my-pcr-products-have).
Regarding claims 23, 25, and 29-31, Fredriksson teaches contacting a nucleic acid sample with two or more primer pairs for two or more target nucleic acids under template dependent primer extension reaction conditions (Abstract; Fig. 2; Fig. 5). Fredriksson teaches that primers have a 3’ target binding portion (Fig. 2). Fredriksson teaches certain ligases require the presence of 5’ end phosphate group to achieve DNA ligation and that one or both primers of a primer pair can be 5’ phosphorylated (pg. 16, para 1, spanning, pg. 17; pg. 23, lines 1-2).
Fredriksson teaches the multiplex nucleic acid reaction may be PCR, in which two primers are designed to prime nucleic acid synthesis toward each other on opposite strands of the target sequence and through repeated cycles of melting, priming, and extending/synthesis, multiple specific target amplicons are formed, resulting in a double-stranded target amplicon bounded by the forward and reverse primer sequences (pg. 10, para 3, lines 10-20). Fredriksson teaches alternative exemplary multiplex amplification reactions including SDA (pg. 10, para 2, lines 5-9).
Thus, in teaching the forward and reverse primers are designed to prime nucleic acid synthesis toward each other on opposite strands of the target sequence and performing repeated cycles of melting [i.e., denaturing], priming [i.e., contacting/annealing a target or extended nucleic acid with a first or second primer], and extending [i.e., forming an extended nucleic acid strand] and that one/both primers may be 5’ phosphorylated so as to enable ligation, Fredriksson teaches steps (a)/(i); (b)/j); (c)/(k); (d)/(l); and (e)/(m).
Fredriksson teaches the target amplicons are denatured prior to placing the sample under stringent hybridization conditions to promote strand separation of double stranded amplicons, which allows the circularization template oligonucleotides to anneal to complementary sequences present at the ends of the cognate target amplicons (similar to the annealing in a standard PCR reactions), wherein denaturation (or strand separation) may be carried out by any convenient method (pg. 12, lines 33 through pg. 33 line 10). Fredriksson teaches hybridizing circularization template oligonucleotides to single-stranded target amplicons [i.e., circularization of targets to form circularization complexes] (pg. 15, lines 30-33; Fig. 3).
Fredriksson teaches that more than one circularization target oligonucleotide may be provided for target amplicons generated by a primer pair (pg. 18, para 1). Fredriksson further teaches that Taq polymerase is known to sometimes add an additional “A” nucleotide to the 3’ end of an amplified product, such that two distinct target amplicons are generated when using Taq: those that have an additional “A” and those that don’t, i.e., the blunt end amplicon (pg. 18, para 1). Fredriksson teaches that to circularize both of these target amplicon species, two circularization oligonucleotides [i.e., bridging oligonucleotides] can be employed, one that will form a circularization complex with the additional “A” target amplicon and one that will form a circularization complex with the blunt end amplicon (pg. 18, para 1).
Thus, Fredriksson teaches a bridging oligonucleotide that further comprises an additional segment consisting of 1 T nucleotide base between the 5’ and 3’ segments to base-pair with one non-template-determined nucleobase units incorporated in the extended strand to be circularized (instant claim 25) and one without such an additional segment capable of binding to the other extended strand generated by the primer pair, thereby teaching steps (f) and (g)/(n) and (o).
Fredriksson teaches use of a DNA ligase, e.g., T4 ligase, to circularize the circularization complex (pg. 18, para 1; Fig. 2).
Thus, Fredriksson teaches steps (h)/(p).
For steps (e)/(g) and (m)/(o), Fredriksson teaches that the 3’ end of the extended strand has hydroxyl group because Fredriksson teaches ligation of the extended strand (e.g., Fig. 2; Fig. 4; Fig. 5; Fig. 10; pg. 12, para 1; pg. 13, para 2, spanning pg. 14; pg. 14, para 1, spanning pg. 15), evidenced by MSK. While Fredriksson does not explicitly teach that the extended strand has a 3’ hydroxyl group, it is inherently taught because the ligation reaction requires both a 5’ phosphate and 3’-OH-terminated strand, as evidenced by MSK (DNA Ligase Reaction: “DNA ligases catalyze the joining of a 5’-phosphate-terminated strand to a 3’-hydroxyl-terminated strand…In the third step, ligase catalyzes attack by the 3’-OH … to join the 2 polynucleotides”).
Fredriksson teaches that by multiplex nucleic acid amplification reaction is meant that more than one primer pair specific for a distinct target nucleic acid sequence is included in the reaction, wherein the number of target-specific primer pairs in a multiplex amplification reaction is 2 or more (pg. 9, para 1).
In teaching that the reactions are multiplex and the steps are performed with the two or more primers, Fredriksson teaches that they are performed at the same time and in the same reaction mixture (instant claims 30 and 31).
Regarding claims 26-27, Fredriksson teaches that the target nucleic acid may be double or single-stranded when contacted with the primers by teaching that the target nucleic acid can be cDNA (col 7, para 3: “the nucleic acid sample can be any of a wide variety [of] types, including… cDNA”), evidenced by NEB. While Fredriksson does not explicitly teach that a target nucleic acid is single stranded, it is inherently taught because “cDNA” may be either single stranded or double stranded, as evidenced by NEB (para. 1: “Reverse transcriptases (RTs) use an RNA template and a short primer complementary to the 3' end of the RNA to direct the synthesis of the first strand cDNA, which can be used directly as a template for the Polymerase Chain Reaction (PCR)…Alternatively, the first-strand cDNA can be made double-stranded using DNA Polymerase I and DNA Ligase.”)
Regarding claim 32, Fredriksson teaches that the circularization template is immobilized on a solid support (col 12, lines 18-19).
Fredriksson fails to teach:
that the denaturing in steps (c) and/or (f) comprises extension of a displacer primer that anneals 3’ of the primers used in bridging (claim 23);
that the extensions of the first primer displaces the complementary strand from the duplex formed from the target nucleic acid (claim 28)
Walker teaches teaching Strand Displacement Amplification (entire document), which comprises use of at least one displacer primer in an amplification with opposite strand-facing inner primers (Fig. 1 and 2).
Namely, Walker teaches that an SDA reaction comprises contacting a target nucleic acid with a first primer having a 3’ target binding segment (e.g., S1) and forming a first extended nucleic acid strand duplexed to the target nucleic acid; displacing [i.e., denaturing] by extending a displacing primer (e.g., B1) that anneals to a position on the target nucleic acid 3’ from the first primer; annealing a 3’ segment of a second primer (e.g., S2) to the first extended strand and forming a second extended nucleic acid duplexed to the first extended strand; and displacing [denaturing] with primer extension of a second displacing primer (e.g., B2) (Fig. 1; pg. 1693, Results, para 2).
Walker teaches that the SDA amplification also results in at least one non-templated 3’ A by teaching that it utilizes an exo- Klenow fragment, evidenced by NEB – Ends. While Walker does not explicitly teach that SDA or the exo- Klenow fragment results in at least one non-templated base, it is inherently taught because the exo- Klenow fragment utilized in Walker (entire document, e.g., Fig. 1 and 2) results in a 3’ A end, evidenced by NEB – Ends (DNA manipulation).
Walker teaches that the steps are performed for both strands at the same time/in the same mixture (Figs. 1 and 2; pg. 1692, col 1, SDA Reactions).
It is noted that Walker also teaches that SDA comprising a target generation scheme that can be applied techniques separate from SDA as a means of conveniently producing double-stranded fragments with 5’ and 3’ sequences modified as desired (Abstract), including performing PCR reactions with multiple primers and a DNA polymerase possessing strand displacement activity (pg. 1696, col 1, para 4).
Walker teaches that rather than an initial heat denaturing [to achieve single-stranded template], an alternative SDA design utilizes restriction enzyme digestion cleavage of a DNA sample [i.e., a duplex template] to enable target amplification (pg. 1691, Introduction). Walker teaches that while such complicates the experimental protocol and requires convenient enzyme restriction sites, such a protocol is “powerful”. Walker also teaches such cleavage with restriction enzymes to enable binding of primers to dsDNA for analogous 3SR (pg. 1696, col 1, para 2) (instant claim 28).
Walker teaches that SDA is able to amplify low target numbers at 37 C, unlike PCR which can only achieve sensitivity when non-specific priming reactions are diminished by stringent/high temperature reaction conditions (pg. 1695, col 2, para 3).
Walker teaches that the target generation scheme using a DNA polymerase with strand displacement ability and the nested primer sets analogous to B1, B2, S1, and S2 should enhance PCR and improve the amount of amplification in early cycles and up to 2x in later cycles (pg. 1696, col 1, para 3).
Therefore, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to have utilized the SDA-based amplification of Walker according to Fig. 1 as described above, which includes displacer primers 3’ of the first and second primers, in the multiplex amplification and bridge circularization of Fredriksson as Fredriksson teaches SDA as a species of the genus of multiple amplification of the invention, wherein such a species would be obvious as a means of displacement. See MPEP 2144.08. Additionally, the artisan would be so motivated as SDA is able to amplify low target number without high temperature reaction conditions, as taught by Walker (e.g., for resource-limited settings with limited access to thermal cyclers). Alternatively, it would have been obvious to the artisan before the effective filing date of the claimed invention to have utilized the SDA-style displacer primers of Walker in a PCR-based reaction of Fredriksson wherein some of the denaturing would comprise extension of the outer displacer primers as Walker suggests that such nested primer sets in such a PCR application should enhance PCR and improve the amounts of amplicons both in the early and later cycles (instant claim 23).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the bridging oligonucleotide consisting of a T nucleotide, given the teachings of Fredriksson regarding A templated bases from polymerase, such would likewise be obvious with Walker’s SDA polymerase in either alternative as it too adds a non-templated base, motivated by the desire to enable effective ligation (instant claim 23).
Further, where the target may be a duplex when contacted by a target nucleic acid in step (a), it would be obvious to utilize the restriction enzyme digestion to prepare the target, as suggested by Walker, as an alternative species of target preparation to heat denaturing so as to enable to first primer to perform displacement, at least because Walker teaches that such preparation is powerful and notes it for use with analogous methods (instant claim 28). See MPEP 2144.08.
There would be a strong expectation of success as both methods are directed to PCR and/or SDA amplification of nucleic acids and such amounts to the application of a known technique to a known method.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fredriksson (WO 2008/033442 A2; as cited in the IDS dated 02/11/2025) in view of Walker (Walker GT, et al. Strand displacement amplification--an isothermal, in vitro DNA amplification technique. Nucleic Acids Res. 1992 Apr 11;20(7):1691-6), as evidenced by MSK (DNA damage recognition and repair by DNA ligases. Memorial Sloan Kettering Institute. Accessed 2024 Nov 12. Available at: https://www.mskcc.org/research/ski/labs/stewart-shuman/dna-damage-recognition-and-repair-dna-ligases), NEB (Reverse Transcription (cDNA synthesis), New England Biolabs. Accessed: 2024 Nov. 13. Available at: https://www.neb.com/en-us/applications/cloning-and-synthetic-biology/dna-preparation/reverse-transcription-cdna-synthesis), NEB – Ends (What ends will PCR products have? [Internet]. New England Biolabs; 2023 [cited 2025 Oct 11]. Available from: https://www.neb.com/en-us/faqs/2023/07/25/what-ends-will-my-pcr-products-have) as applied to claim 23 above, and further in view of Patel (US 2009/0280538 A1; as cited in the IDS dated 02/15/2022).
Regarding claim 33, in the method of Fredriksson in view of Walker as evidenced by MSK, NEB, and NEB – Ends, Fredriksson teaches that one or more of the target amplicons in a low background amplification reaction of the present invention [i.e., amplifications performed after digesting linear species to remove background; see pg. 20, lines 33 through pg. 21 lines 21] are subjected to nucleic acid sequence analysis, wherein Sanger type sequencing can be performed using one or both of the initial multiplex amplification primers as a sequencing primer(s); pyro-sequencing or other sequencing by synthesis is also applicable (col. 16, para 5). Fredriksson teaches amplification of circular DNA (Fig. 4).
However, Fredriksson fails to teach a sequencing reaction with the generation of a nascent strand using the close nucleic acid structure serving as template.
Patel teaches performing a sequencing reaction with a closed nucleic acid serving as a template for the generation of a nascent strand from which the sequence of a target nucleic acid is read with the sequencing reaction proceeding around the closed nucleic acid (para [0040]: “Any of the preceding methods of generating closed single stranded nucleic acid loops or single-stranded nucleic acid fragments can further include the step of sequencing the single-stranded nucleic acids, e.g., in a high-throughput sequencing system, such as an array of zero-mode waveguides (ZMWs).”; para [0017]). Patel further teaches that single molecule real-time sequencing (SMRT) is can be used to sequence single-stranded nucleic acid fragments or loops, e.g., produced by any of the methods described herein, in a high-throughput manner, wherein SMRT technology relies on arrays of multiplexed zero-mode waveguides (ZMWs) (para [0112]).
Therefore, it would have been obvious to one of ordinary skill in before the time of filing to substitute the sequencing in the combined method with the method of sequencing of loops of Patel, motivated by the desire to utilize a high-throughput option for sequencing, as taught by Patel, wherein such also represents an obvious species of the genus of sequencing. There would be a strong expectation for success as the artisan is substituting one known sequencing method for another.
Double Patenting
Claims 23, 25-28, 32 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US 10,081,825 B2 in view of Fredriksson (WO 2008/033442 A2; as cited in the IDS dated 02/11/2025; citations below are based on the equivalent US Patent US 8,293,501 B2), Walker (Walker GT, et al. Strand displacement amplification--an isothermal, in vitro DNA amplification technique. Nucleic Acids Res. 1992 Apr 11;20(7):1691-6) and Patel (US 2009/0280538 A1; as cited in the IDS dated 02/15/2022) as evidenced by MSK (DNA damage recognition and repair by DNA ligases. Memorial Sloan Kettering Institute. Accessed 2024 Nov 12. Available at: https://www.mskcc.org/research/ski/labs/stewart-shuman/dna-damage-recognition-and-repair-dna-ligases), NEB (Reverse Transcription (cDNA synthesis), New England Biolabs. Accessed: 2024 Nov. 13. Available at: https://www.neb.com/en-us/applications/cloning-and-synthetic-biology/dna-preparation/reverse-transcription-cdna-synthesis), and NEB – Ends (What ends will PCR products have? [Internet]. New England Biolabs; 2023 [cited 2025 Oct 11]. Available from: https://www.neb.com/en-us/faqs/2023/07/25/what-ends-will-my-pcr-products-have.
Both sets of claims are directed to annealing a first primer to a target nucleic acid where the first primer has a sequence complementary to a portion of a target nucleic acid and extending a first primer to form a first duplex nucleic acid [wherein such would be complementary to the target]; removing said first duplex nucleic acid to produce a first nucleic acid; annealing a second primer that has a sequence substantially identical to a second portion of the target nucleic acid and a first non-nature nucleotide at its 5’ end and extending said second primer with polymerase to produce a second duple nucleic acid; removing said first nucleic acid from said second duplex nucleic acid to produce a second nucleic acid; annealing a bridging oligonucleotide to said second nucleic acid, wherein said bridging oligonucleotide has sequence substantially complementary to said second primer and a sequence substantially identical to said first primer, forming a circular second nucleic acid , wherein the 3’- end and 5'- termini of said circular second nucleic acid is joined by ligase.
‘825 teaches annealing the second primer to give exponential amplification (claim 1, F).
As discussed and cited in the 103 above as with the primers of Fredriksson, ‘825 inherently teaches that the 5’ of the second primer is phosphorylated because it participates in ligation, evidenced by MSK.
‘825 fails to explicitly teach:
the bridging oligonucleotide comprises 1-4 T nucleotide bases (claim 23) or consists of 1, 2, 3, 4, or more T nucleotide bases (claim 25);
the use of displacer primers in the denaturation (claim 23 and 28);
the strandedness of the template (claims 26-27);
attachment of the bridging oligonucleotide to a solid support (claim 32);
that the exponential amplification around the closed nucleic acid may be as part of a sequencing reaction (claim 33).
As discussed and cited in the 103 rejection, Fredriksson and Walker, as evidenced by MSK, NEB, and NEB ends, teach or suggest:
use of a bridging oligo with 1 T nucleotide base (claims 23 and 25);
the strandedness of template molecules (claims 26-28);
the use of displacer primers in the denaturation steps (claims 23 and 28);
attachment of the bridging oligo to a solid support (claim 32).
Fredriksson teaches that there is need for improve methods to reduce the impact of non-target amplicon generation in multiplex PCR (pg. 1, Background, para 1), and using bridge oligonucleotides with and without with a T when using a polymerase known to sometimes add an additional A nucleotide to the 3’ end of the amplified product to enable circularization (pg. 18, para 1), various template molecules known in the art to be single or double stranded (see 103 above, as evidenced by NEB; see also pg. 10, para 5), and using the solid support to wash (pg. 17, line 28 through pg. 18, line 1).
Walker teaches that SDA is able to amplify low target numbers at 37 C, unlike PCR which can only achieve sensitivity when non-specific priming reactions are diminished by stringent/high temperature reaction conditions (pg. 1695, col 2, para 3).
Walker teaches that the target generation scheme using a DNA polymerase with strand displacement ability and the nested primer sets analogous to B1, B2, S1, and S2 should enhance PCR and improve the amount of amplification in early cycles and up to 2x in later cycles (pg. 1696, col 1, para 3).
As discussed and cited in the 103 rejection, Patel teaches:
using a closed nucleic acid in a circular sequencing reaction that amplifies along a circular template (claim 33).
Patel teaches that the method of sequencing using zero-mode waveguides/SMRT sequencing is a high-throughput method. Patel teaches that SMRT is a sequencing technology used for loops in which a DNA polymerase incorporates complementary fluorescently labeled nucleotides into a DNA strand being synthesized (para [0112]). Patel teaches that DNA sequencing enables the determination of the order of nucleotide bases (para [0100]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a bridging oligo with 1 T in the method of ‘825, as taught by Fredriksson, motivated by the desire enable circularization of templates with an A added at the 3’, as taught by Fredriksson.
It likewise would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select either a single- or a double-stranded template as such are obvious to try within the field of nucleic acids as there are two conventional options for strandedness, where there would have been a strong expectation for success. Alternatively/additional, such would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select from among the templates of Fredriksson as obvious species of the genus of nucleic acid templates, wherein at least cDNA may be either single- or double-stranded, evidenced by NEB.
Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the displacer primer(s) of Walker in the combined method, as SDA is a species of the genus of amplifying, wherein the removal of the nucleic acid by displacer primer would follow, as demonstrated at least by Fredriksson. Further, Walker teaches the motivation of an improvement that such enables amplification of low target numbers at 37 C without the need for high temperature conditions. The artisan would understand that such isothermal conditions would allow the method to be compatible with a greater number of settings (e.g., those with limited access to thermal cyclers). Additionally/alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized them in an adapted PCR as part of the displacement, motivated by the desire to increase the amplification output as suggested by Walker.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize restriction enzymes for duplex species of templates as an obvious genus of template preparation, as suggested by Walker, which would enable displacement by the first primer without heat denaturation.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a bridging oligonucleotide attached to a solid support in the combined method to enable wash steps, as suggested by Fredriksson, and/or to have increased the local concentration of the reagents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to applied the amplification of the closed nucleic acid with the with the SMRT sequencing of Patel, motivated by the desire to determine the order of the nucleic acid bases, wherein SMRT is an obvious species of sequencing applicable to such loops, as taught by Patel. The artisan would have been further motivated by the desire for the high throughput nature of the sequencing technology.
Response to Arguments
Applicant's arguments filed 04/16/2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 7-8 that the alleged sources of motivation for combining the references are of great generality. Applicant argues that “amplifying low amounts of target molecules or increasing the volume of amplification ... is no more appliable to the presently claimed methods than any other method of amplification and detection”. Applicant argues that such motivations do not suggest which elements of which references to combine or how to combine them. Applicant notes that rejections cannot be mere conclusory statements, citing KSR and Adapt Pharm Operations Ltd. v. Teva Pharms., and that the courts have found that merely proposing a benefit might result when the benefit did not suggest the claimed modification was insufficient, citing Innogenetics v. Abbot.
Applicant alleges that without cognizable motivation a prima facie obviousness has not been established for the 103 or double patenting rejections.
The arguments have been considered but they are not persuasive. While the examiner appreciates that the Applicant finds the rationale “without cognizable motivation”, the examiner respectfully disagrees. Application of a known technique to improve a method in a sample way (e.g., the application of the displacing primers in the PCR methods of Fredriksson to increase the “volume”, i.e., output, of the amplification) or substitution of the PCR method with the SDA (the (a)/(i); (b)/j); (c)/(k); (d)/(l); and (e)/(m) steps with the elements mapped in the description of Walker) motivated by the ability to amplify low amounts of a target molecule where the components of each method were known in the art are both supported motivations described in MPEP 2143. In the field of nucleic acid amplification, increasing amplicons and/or allowing for amplification in low template samples would be motivating to an artisan.
However, for the sake of compact prosecution, these rejections and those of the remaining 103 and double patenting rejections have been rewritten to improve clarity.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emma R Hoppe whose telephone number is (703)756-5550. The examiner can normally be reached Mon - Fri 11:00 am - 7:00 pm.
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/EMMA R HOPPE/Examiner, Art Unit 1683
/NANCY J LEITH/Primary Examiner, Art Unit 1636
Prosecution Insights